A randomized interventional parallel study to evaluate the effect of pelvic floor muscle training with stabilization exercises of high and low intensity in women with stress urinary incontinence: The PELSTAB study

INTRODUCTION: The effect of different intensities of pelvic floor muscle training (PFMT) assessed by 2D/3D ultrasound (USG) have not been sufficiently monitored in the literature. The objective of the study will be to evaluate the effect of this intervention by assessing the change in incontinence episode frequency, hiatal area (HA) and hiatal diameter by 2D/3D USG and quality of life over 12 weeks of treatment. METHODS: Using a randomized interventional parallel study, patients will be assigned to groups A and B using simple software randomization according to odd and even patient sequence numbers. The following methods will be used for evaluation: change in incontinence episode frequency, power and endurance of pelvic floor muscles assessed by perineometer (in cmH(2)O), HA (in cm(2)) during contraction, Valsalva manoeuvre assessed by 3D USG, hiatal diameter assessed by 2D USG, the Incontinence Quality of Life scale (I-QoL) and the Patient Global Impression of Improvement score (PGI-I). Interventions: Group A, high-intensity PFMT 5 times a week for 30 minutes per day. Group B, low-intensity PFMT twice a week for 15 minutes per day. The duration of the intervention will be 12 weeks. DISCUSSION: The study protocol presents the starting points, design, and methods of the PELSTAB Study. We expect that, after 12 weeks of high-intensity PFMT, women with stress urinary incontinence will have significantly less incontinence episode frequency, better reduction of HA during contraction and Valsalva manoeuvre, higher power and endurance of pelvic floor muscles and better quality of life compared to the group with low-intensity PFMT. REGISTRATION: This study was registered in the ClinicalTrials.govNCT04340323.